Acuity Surgical Devices, LLC - FDA 510(k) Cleared Devices

Acuity Surgical Devices, LLC develops spinal implant solutions for surgeons and patients. Based in Irving, Texas, the company delivers complete systems for lumbar, cervical, and biologic spine surgery since 2013.

The company has received 8 FDA 510(k) clearances from 8 total submissions, all in Orthopedic devices. Clearances span 2021 to 2025, demonstrating sustained regulatory activity and market presence in spinal implant technology.

Acuity's product portfolio includes stand-alone anterior lumbar fusion systems, modular cervical fixation platforms, posterior lumbar interbody devices, and expandable cage systems. The company also offers aseptically processed allograft solutions for bone regeneration and repair.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

Regulatory submissions have been managed by Acknowledge Regulatory Strategies, LLC and RQM+.